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BELKYRA™ Indications for Use

BELKYRA™ is an injectable solution containing deoxycholic acid, a substance naturally produced by the body to aid in the digestion of fats. BELKYRA is used in adults to treat submental fat (commonly referred to as a “double chin”) when it has a significant psychological impact on the patient. This treatment is not intended for individuals who are obese or have body dysmorphic disorder (a distorted view of one’s appearance).

• Primary target: Reduction of submental fat under the chin.
• Active ingredient: Deoxycholic acid.
• Mechanism of action: Breaks down fat cells, which are then naturally eliminated by the body.

BELKYRA™ Dosage Information

BELKYRA is injected subcutaneously (under the skin) into the fat tissue below the chin. The number of injections and treatment sessions will vary based on the patient’s individual needs.

• Injection volume: 0.2 mL per injection site, spaced 1 cm apart.
• Maximum dosage: 10 mL per treatment session (equivalent to 50 injections).
• Number of sessions: A maximum of 6 sessions can be performed. Most patients see improvement after 2 to 4 treatment sessions.
• Interval between sessions: At least 4 weeks between each session.

BELKYRA should only be administered by a trained physician or healthcare professional who has expertise in submental anatomy and the appropriate qualifications to deliver the injections.

BELKYRA™ Side Effects and Precautions

Like any medical treatment, BELKYRA comes with potential side effects. Some are common and expected due to the nature of the procedure, while others are more severe but less frequent.

• Very common side effects (affecting more than 1 in 10 people):
  • Pain at the injection site.
  • Swelling, bruising, numbness, or hardness at the treatment area.
  • Redness, itching, or tingling sensations.
• Common side effects (affecting 1 to 10 in 100 people):
  • Bleeding at the injection site.
  • Skin discoloration.
  • Warmth or tightness in the treatment area.
  • Nerve injury leading to temporary facial muscle weakness or an uneven smile.
  • Difficulties swallowing (dysphagia) and nausea.
• Uncommon side effects (affecting 1 to 10 in 1,000 people):
  • Hair loss at the injection site.
  • Skin ulcers, scarring, or hives.
  • Changes in sensation in the mouth or cheeks.

If you experience severe side effects like difficulty swallowing, tissue necrosis, or an uneven smile, contact your doctor immediately. Tissue damage around the injection site can lead to scarring, and in such cases, BELKYRA should never be used again.

BELKYRA™ Clinical Studies or Real-World Outcomes

Clinical studies for BELKYRA have shown effective results in the reduction of submental fat. Most patients required 2 to 4 treatment sessions to achieve a satisfactory outcome, with a maximum of 6 sessions allowed. Significant improvement in the reduction of chin fat is typically visible within 4 weeks of each session, and continued improvement is seen over time as the body naturally eliminates the fat cells.

• Improvement rate: Most patients observe a visible reduction of submental fat after 2-4 sessions.
• Treatment duration: Each session involves multiple injections, with the results continuing to improve over a few months.

Drug Interactions

Before receiving BELKYRA, it is important to inform your doctor if you are taking any medications, as interactions can occur. Some medications may increase the risk of side effects or complicate the treatment process.

• Medications to avoid:
  • Blood-thinning medications may increase the risk of bleeding at the injection site.
  • Antibiotics or anti-inflammatory drugs should be discussed with your healthcare provider.

Special Considerations

• Pregnancy and breastfeeding: The effects of BELKYRA during pregnancy or breastfeeding are not known. Therefore, it is recommended that BELKYRA not be used during these periods.
• Sodium content: BELKYRA contains 4.23 mg of sodium per mL, which may be relevant for patients on a sodium-restricted diet.
• Children and adolescents: BELKYRA is not indicated for use in individuals under the age of 18.

BELKYRA™ Procedure and Preparation

BELKYRA injections should be administered only by qualified physicians or healthcare professionals with specific training in submental anatomy. Careful consideration is required to ensure the treatment is suitable, particularly in patients with excess skin laxity or prominent platysmal bands, as these conditions may result in an undesirable outcome following the fat reduction.

• Administration tips:
  • Prior to injection, outline the treatment area using a 1 cm² injection grid to mark injection sites.
  • Injection should be performed perpendicular to the skin, avoiding the marginal mandibular nerve to reduce the risk of nerve injury.
  • Cooling packs or local anesthesia may be applied to reduce discomfort during the procedure.
• Injection precautions:
  • Avoid injecting above the inferior border of the mandible.
  • Ensure injections remain within the submental fat area to avoid damaging the platysma muscle or causing other complications.